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Ameditech, Inc.

USA · San Diego

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

9listed device types

Class I 1Class II 8Class III 0

plus 9 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States9 registration records, 14 510(k), 0 PMA

Manufacturer names merged into this page: Ameditech, Inc.

FDA 510(k) clearances by year

62001

12002 · K023126

22004 · K042975

22005 · K053175

12006 · K063015

22011 · K113501

FDA listed device types

showing 8 of 9

Test, Methamphetamine, Employment And Insurance Testing, Exempt 1Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt 1Test, Methadone, Employment And Insurance Testing, Exempt 1Test, Cannabinoid, Employment And Insurance Testing, Exempt 1Test, Opiates, Employment And Insurance Testing, Exempt 1Test, Barbiturate, Employment And Insurance Testing, Exempt 1Test, Amphetamine, Employment And Insurance Testing, Exempt 1Test, Benzodiazepine, Employment And Insurance Testing, Exempt 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K113501	AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)	2011-12-05
US	K113046	AMEDITECH IMMUTEST MILTI-DRUG SCREEN	2011-11-10
US	K063015	AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150	2006-12-20

Ameditech, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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